MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR)

Model Number	125035
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit air did not left out.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample was returned for evaluation.Visual examination of the returned sample shows the shape of the tubing has been altered using the stylet wire.The stylet wire was replaced and the returned sample was inflated and inflated without issue.Both cuffs fully deflated and no issue noted.The stylet wire was removed and the returned sample was re inflated and both cuffs inflated without issue.Both cuffs were fully deflated and no issue noted.The reported defect could not be detected when deflating the tube with the stylet wire contained in the tubing or when it was removed.The most probable root cause is the tracheal cuff was stretched over the tracheal cuff notch during the deflation stage of the process.All of our products under go a four hour inflate/deflate test prior to release and it is at this stage of the process that any defects are removed from the lot.Corrective actions have been implemented to mitigate this issue.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 9186079
• Report Number: 8020889-2019-00143
• Device Sequence Number: 19743663
• Product Code: BTS
• UDI-Device Identifier: 30884522008734
• UDI-Public: 30884522008734
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 125035
• Device Catalogue Number: 125035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1